Outcomes of micra leadless pacemaker implants in centers with and without cardiac surgery

Abstract Background The Micra leadless pacemaker provides a lead-free alternative to traditional transvenous pacemakers, significantly reducing complications associated with leads and device pockets. Although the initial application of leadless pacemakers was limited to centers with on-site cardiac surgery due to the technical demands, recent evidence suggests that implantation can be safely extended to centers without cardiac surgery capabilities. However, comprehensive comparisons of outcomes between these settings remain scarce. Aims This study aimed to assess the safety, feasibility, and clinical outcomes of Micra leadless pacemaker implantation across centers with and without cardiac surgery. The analysis focused on acute complications, device performance, and patient follow-up. Methods A retrospective study was conducted on 1,899 patients who received a Micra pacemaker between May 2015 and September 2024 at 23 centers participating in the One Hospital Clinical Service (OHCS) initiative. Patients were classified into two groups: those treated at centers with cardiac surgery (CS, n=1,025) and those without (No-CS, n=874). The primary endpoint was the rate of acute complications within 15 days post-implantation. Secondary endpoints included device performance and clinical outcomes at 12 months. Results The overall acute complication rate was 0.6%, with no significant difference between CS (0.5%) and No-CS (0.8%; p=0.391) groups. Procedural times were shorter in No-CS centers (41.2 ± 19.8 minutes) compared to CS centers (46.1 ± 19.3 minutes; p<0.001), and fluoroscopy times also tended to be lower. Both groups showed comparable device performance and patient outcomes during the follow-up period. Differences in procedural techniques were noted; for example, No-CS centers more frequently utilized venography to facilitate the introduction of the delivery system, while CS centers used contrast imaging more often before device release. Conclusion The findings of this study support that Micra leadless pacemaker implantation can be safely performed in centers without cardiac surgery, achieving comparable outcomes to those with on-site surgical facilities. These results suggest that with adequate training and emergency protocols, non-surgical centers can safely adopt leadless pacemaker technology, potentially expanding access to this advanced pacing solution across diverse healthcare settings.